Clinical trial · Interventional
Calm for Cancer Patients Receiving Chemotherapy
Can a Mindfulness Meditation App Reduce Emotional Distress in Colorectal Cancer Patients Undergoing Adjuvant Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was never submitted to the IRB so never received permission to or enrolled any subjects
Summary
Brief summary (as posted)
Chemotherapy is a common strategy used to treat colorectal cancer patients, but is often leads patients and survivors to experience a host of symptoms, of which acute emotional distress is a major concern. Smartphone-based meditation via an already-developed app (i.e., Calm) is a unique and novel way of providing a potentially helpful symptom-management strategy to colorectal cancer patients and survivors both during their chemotherapy treatment sessions for the management of distress and between treatment sessions for the management of other more chronic symptoms. Our hypothesis is that colorectal cancer patients using the Calm smartphone app throughout their chemotherapy treatment will see lower psychological distress during individual chemotherapy treatment sessions, greater chemotherapy tolerability, lower chemotherapy toxicity symptoms, lesser fatigue, and higher quality of life as compared to a usual care control group. Colorectal cancer patients (N=30) will be randomly assigned to an intervention (n=15) or control group (n=15) for the duration of their chemotherapy treatment, with study outcome measurement occurring throughout their treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Colorectal | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calm Meditation Mobile App | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Calm Meditation
- description
- Participants in the Calm group will be asked to use the Calm app ad libitum during their time spent receiving chemotherapy at the Mays Cancer Center (\~2 hours) and while at home between treatment cycles ad libitum. Participation will be measured during the entire intervention using internal tracking systems within the app (i.e., # of times logged in, type of meditation accessed, time spent meditating, date and time of meditation accessed). This data will be provided to us through data coordinator of the app.
- interventionNames
- Behavioral: Calm Meditation Mobile App
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- The usual care control group will not be offered anything to listen to during their chemotherapy treatment cycles or when they are between chemotherapy treatment cycles. They will receive their treatment as intended without any additional intervention.
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have a colorectal cancer diagnosis and waiting the beginning of adjuvant chemotherapy treatment at the Mays Cancer Center University of Texas (UT) Health San Antonio * Own a mobile smartphone (iPhone with iOS 9.0 or later or an Android 4.1 or later) * Willing to download a mobile app * Able to read and understand English or Spanish * Aged 18 years or older * Willing to be randomized to one of two groups Exclusion Criteria: * Meditation or meditative movement practice (i.e., yoga, tai chi, qigong) of greater than or equal to 60 min/month in the past six months * Use of any consumer-based meditation app * Reside outside of the united states
References
Publications (0)
Data not yet available